• U.S. Food and Drug Commissioner Scott Gottlieb, M.D., announced on March 8, that the Agency was deactivating a 2016 import alert that prevented genetically engineered (GE) salmon from entering the U.S. By way of background, in 2015, FDA approved a New Animal Drug Application (NADA) related to AquAdvantage Salmon after determining that it met the statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. AquaAdvantage Salmon contains intentional genomic alterations (IGAs) and is genetically engineered to reach market size more rapidly than its non-GE, farm-raised Atlantic salmon counterpart.
  • However, in 2016, Congress directed FDA not to allow food that contains GE salmon into commerce until final GE labeling guidelines were in place. As a result, FDA implemented the import alert that prevented GE salmon from entering the U.S. With the import alert still in place, in 2018, FDA approved a supplemental NADA submitted by Maynard, Massachusetts-based AquaBounty Technologies, Inc. requesting FDA’s approval to raise AquaAdvantage Salmon at a land-based contained facility near Albany, Indiana. The original NADA only specified AquaBounty’s facility on Prince Edward Island, Canada, where the salmon eggs are produced, and the company’s grow-out facility in Panama.
  • FDA stated, in a press release, that it believes that the Congressional mandate was satisfied when the U.S. Department of Agriculture (USDA) issued the final rule implementing the National Bioengineered Food Disclosure Standard (for more information on the final rule, see our Dec. 20, 2018 blog). “Therefore, the FDA is deactivating the import alert that prevented food from AquAdvantage Salmon, including salmon eggs used to grow the fish, from entering the U.S.,” the Agency wrote. FDA added that it “is committed to supporting innovation and ensuring safety in the biotechnology space, including the use of IGAs in animals.”
  • Not everyone agrees with FDA’s decision. In a press release issued the same day that FDA made the announcement, U.S. Senator Lisa Murkowski (R-AK) stated, “USDA’s new guidelines don’t require adequate mandatory labeling and don’t suffice as giving consumers clear information. Instead, they will only confuse people. I continue to have serious concerns about splicing DNA from two animals to produce a new marketable fish, essentially creating a new species.”
  • The next steps for AquaBounty Technologies is to have its Albany, Indiana recirculating aquaculture system (RAS) facility certified by state authorities and then begin production, Sylvia Wulf, the company’s new CEO, told Undercurrent News (registration required). Since once the eggs arrive from Canada it will take about 18 months to grow the fish to market size, Wulf predicted that sales of product from the company’s Albany facility would begin about the third quarter of 2020.
  • The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is concerned with an increase in recent years in the number of recalls of meat and poultry products contaminated with foreign materials.  Notably, in many cases, the recalling establishments had received multiple customer complaints before these recalls.  Customer complaints for meat and poultry products can often signal adulteration or misbranding issues that trigger regulatory requirements under 9 C.F.R. Part 416 – Sanitation, Part 417 – Hazard Analysis and Critical Control Point (HACCP) Systems, and Part 418 – Recalls.  FSIS recommends, but does not require, that an establishment develop a program to receive and process customer complaints.
  • On March 8, 2019, FSIS issued draft Guidelines for Industry Response to Customer Complaints to provide reference material on best practices and recommendations on how to receive, investigate and process customer complaints.  The new guidelines encompass all types of customer complaints, including quality issues that do not trigger regulatory requirements.  The new guidelines recommend also consulting a more narrowly focused related document developed by industry in 2018, Industry Best Practices for Customer Complaints of Foreign Material in Meat and Poultry Products.  When the evaluation, investigation, and corrective actions for FSIS regulated products are fully documented and available to FSIS for review upon request under a customer complaint program, the records of the program can be used to fulfill mandatory regulatory requirements.
  • The new FSIS guidelines address the following components of a consumer complaint program:  Customer Complaint Reporting, Substantiation of the Customer Complaint, Establishment Response to a Customer Complaint (including Establishment Response Plan and Investigation, FSIS Notification, and Corrective Actions), and Documentation of the Customer Complaint.  The new guidelines also provide an extensive discussion of 9 C.F.R. § 418.2 (“Notification”), which requires all establishments to report to the agency within 24 hours when they have shipped or received an adulterated USDA-regulated product and that product is in commerce.  FSIS stresses that product containing foreign material is adulterated even when a physical food safety hazard is not present.  Additionally, the new guidelines clarify when product is “in commerce” and when the 24‑hour time period starts.
  • FSIS will respond to public comments received by May 15, 2019 and will update the guideline as necessary.
  • As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) in a November 16, 2018 joint press release, announced an agreement on joint regulation of cell-cultured meat.  Though the framework was not released at the time, the press release indicated that under the agreement, FDA will oversee “cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry”.  As we noted at the time, the scope of USDA inspection was not addressed and the Agencies agreed that no legislation would be necessary to effectuate the joint agreement.
  • On March 7, 2019, USDA and FDA published a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here).  The agreement provides some indication of expected inspectional burdens on industry – the agreement includes a provision that USDA will “require each establishment that harvests cells cultured from livestock or poultry . . . for the purpose of producing human food required to bear the USDA mark of inspection, processes those cells into such human food products, or packages and labels such products, to obtain a grant of inspection, as required by the FSIS regulations.” In addition, USDA will conduct “inspection in establishments where cells cultured from livestock and poultry subject to the FMIA and PPIA are harvested, processed, packaged or labeled, in accordance with applicable FSIS regulations (including sanitation and physical product inspection, Hazard Analysis and Critical Control Point (HACCP) verification, product testing, and records review), to ensure that resulting products are safe, unadulterated, wholesome and properly labeled.” As FDA will oversee cell collection and the development/maintenance of cell banks up and until the harvesting stage, FDA also will conduct inspections at those facilities to ensure compliance with FDA laws and regulations.
  • In contrast, the formal agreement provides no clarity on the statutory basis for USDA regulation.  As opposed to the press release in November, which indicated that no legislation would be necessary, the formal agreement indicates that FDA and USDA “will undertake a joint process to identify any changes needed to statutory or regulatory authorities to effectuate” the agreement.
  • Keller and Heckman will continue to track the regulation of cell-cultured meat.
  • Unlike other product categories regulated by FDA, FDA’s authority over cosmetic products marked in the United States is limited. FDA lacks mandatory recall authority for cosmetics, and manufacturers are not legally required to disclose adverse health effects reported by consumers. Ultimately, companies and individuals who market these products in the U.S. bear the responsibility for the safety and labeling of their products.
  • In 2017, FDA become aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled the suspect products, and on December 22, 2017, Claire’s removed a number of products from its stores. In a statement on March 5, 2019, former FDA Commissioner Dr. Scott Gottlieb and Dr. Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition explained that after Claire’s withdrew and Justice recalled the suspect products, FDA conducted independent tests to determine if some of these products did, in fact, contain asbestos. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice.
  • While suspect Justice products, including the one that tested positive for asbestos were previously recalled from the market, FDA noted that Claire’s has refused to comply with the Agency’s request to recall the products. Because the Agency does not have authority to mandate a recall, FDA issued a Safety Alert, warning consumers to not use three of Claire’s products because they tested positive for asbestos. In essence, the Agency utilized the statement in this case to publicly announce their alleged safety concerns with the products and to point out that Claire’s had failed to comply with FDA’s request. While not a recall, this statement represents a powerful tool for the Agency to communicate concerns with respect to cosmetics.
  • On Tuesday, March 5, FDA Commissioner Scott Gottlieb announced he would resign at the end of the month. Gottlieb, a physician and former deputy commissioner in the George W. Bush administration, was confirmed as FDA Commissioner in May 2017. The resignation was not sought by the White House, as confirmed by a senior White House official. Rather Gottlieb, who commutes weekly to Washington from Connecticut, said he wants to spend more time with his family. In a letter to FDA staff, Gottlieb noted “[t]here’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family these past two years and missing my wife and three young children.”
  • Unlike some former commissioners, during his tenure, Gottlieb focused much of his time on issues related to food and tobacco. For example, as part of its 2018 Strategic Policy Roadmap, FDA signaled its intent to modernize certain standards of identity (SOI) to address current barriers to the development of healthier products while making sure consumers have accurate information about the foods they eat.  Relatedly, under Gottlieb’s direction, FDA requested comments on the use dairy terms in the labeling of plant-based products. See our previous posts on SOI modernization and the plant-based products labeling debate. As for food safety, examples of FDA action include plans to modernize oversight of imported food and the investigation of several product recalls, including the November 2018 romaine lettuce E. coli outbreak. And in April 2018, FDA issued its first ever mandatory recall. Additionally, Commissioner Gottlieb dedicated his efforts to reducing tobacco-related disease and death and curtailing youth access to tobacco products and e-cigarettes. Tobacco- and e-cigarette-related posts can be found here.
  • Prior to his departure, Commissioner Gottlieb vowed to continue to work to cement more of FDA’s pending efforts, to secure the 2020 budget, and to help transition the agency to new leadership. At this time, Commissioner Gottlieb’s replacement has not been announced.
  • The U.S. Food and Drug Administration (FDA) announced several new steps it is taking to combat youth access to tobacco products and e-cigarettes. In a March 4 statement, FDA Commissioner Scott Gottlieb, M.D., pointed out that retailers are on the frontlines of these efforts to reduce the health consequences of tobacco use and nicotine dependence and outlined the actions that the Agency is taking, beginning with ones directed at retailers.
  • First, FDA sent a letter to Walgreen Co.’s corporate management requesting a meeting to discuss the company’s policy on selling tobacco products to kids. Walgreens is currently the top violator among pharmacies that sell tobacco products, with 22% of the more than 6,350 stores inspected by FDA having illegally sold tobacco products to minors. (See our Feb. 8, 2019 blog for more information on previous action that FDA took against retailers, including Walgreens, selling tobacco products to minors.)
  • Second, FDA plans to also hold accountable 15 other national, corporate-owned chains and franchise stores with high rates of violations for illegal sales of tobacco products to minors. The agency will request information on what policies they have in place and what more they can commit to do to prevent youth tobacco sales. “Companies should be on notice that the FDA is considering additional enforcement avenues to address high rates of violations,” stated Dr. Gottlieb said in the statement, adding “Ignoring the law and then paying associated fines and penalties should not simply be viewed as a cost of doing business.”
  • With respect to retailers, Dr. Gottlieb added that FDA will continue to utilize its voluntary national retailer education program called “This is Our Watch,” which includes free resources designed to support retailers’ efforts to educate their staff on enforcing federal laws and regulations.
  • Third, on March 4, FDA sent its first warning letters to several companies for, among other things, selling electronic nicotine delivery system (ENDS) products and a waterpipe tobacco product with labeling and/or advertising that failed to include the required nicotine warning statement.
  • Fourth, FDA sent letters, also on March 4, to a number of governors across the country thanking them for their work to support efforts that led to the more than 81,570 warning letters that the Agency sent to retailers for violating the law, as well as the issuance of more than 19,800 civil money penalties and about 145 no-tobacco-sale orders for repeated violations since FDA began conducting tobacco retailer inspections in 2010.
  • Dr. Gottlieb concluded by stating, “We’ll continue vigorous enforcement activities, with a sustained campaign to monitor, penalize and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products.” He added that FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.

Amazon, Walmart, Costco Sued Over Fake ‘Kona’ Coffee (subscription to Law360 required)

  • Section 43(a) of the Lanham Act (15 U.S.C. 1125) permits a civil action for, among other reasons, “false designation of origin.”  To prevail, a plaintiff must prove the designation of origin is false, that it is used in a commercial advertisement (e.g., a label) in interstate commerce, that it deceives or is likely to deceive in a material way, and it has caused or is likely to cause competitive or commercial injury to the plaintiff.
  • A group comprising all of the coffee farmers in the Kona District of the Big Island of Hawaii filed a class action on February 27, 2019 in the U.S. District Court for the Western District of Washington against the producers and sellers of 19 brands of coffee that are identified as “Kona” but allegedly contain no Kona coffee or only trace amounts.  Defendants include sellers such as Walmart, Costco, Amazon, Safeway, Kroger, Cost Plus/World Market, and Bed Bath & Beyond as well as several producers based in Hawaii and in the mainland.  The plaintiffs point out that only 2.7 million pounds of coffee are grown in the Kona region each year, but more than 20 million pounds of coffee are labeled with the name and they offer a report on analytical testing of trace metals in the allegedly counterfeit coffee to prove that it was not produced in the Kona region (which is said to yield coffee with a distinct flavor profile that commands premium prices).
  • A Hawaiian newspaper reports that the attorneys representing the Kona coffee growers in the Lanham Act lawsuit also plan to file another class-action lawsuit based on the same claims on behalf of consumers who bought allegedly fraudulent Kona coffee.
  • The designation of origin for Kona coffee can be distinguished from the use of common cheese names which, as reported here, have been the subject of longstanding trade disputes between the United States and the European Union.  Whereas “Kona” is clearly used to indicate coffee grown in the Kona region of Hawaii, parmesan and other some other names are used generically to indicate a specific style of cheese and are not necessarily geographical indicators that imply the cheese is produced in a certain place, such as Parma, Italy.

 

 

  • As previously reported in this blog, the 2018 Farm Bill removed hemp – defined as Cannabis sativa L. with less than 0.3% THC on a dry weight basis – from the definition of “marihuana”.  The 2018 Farm Bill also assigned responsibility for regulating the manufacture of hemp to the states under plans approved by USDA or by USDA itself.  As reported on the Marijuana Moment website here, on Wednesday, in a hearing regarding The State of The Rural Economy with the House Agriculture Committee, Sonny Purdue, Secretary of USDA, announced that he thinks the USDA rules will be in place in late 2019 – in time for the 2020 growing season.  He noted that regulation will be further complicated by hemp’s “relationship to other crops that [USDA is] not encouraging.”  On February 27, USDA announced a webinar regarding hemp.
  • We have also reported on FDA’s continuing opposition to the inclusion of cannabis extracts in food or dietary supplements.  As widely reported, included by CNBC in a February 28 hearing with the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations, FDA Commissioner Scott Gottlieb announced he is putting together a working group to develop rules that would permit the use of certain extracts from hemp in food or dietary supplements.  According to Commissioner Gottlieb, FDA is planning a public hearing in April.
  • In tech news, researchers in California have developed modified yeast with genes that create enzymes that essentially brew cannabinoids, including THC and CBD.  Not only could such a method reduce the environmental burden of producing cannabinoids, it would also permit manufacturers to manufacture cannabinoids of extremely high purity for use in pharmaceuticals.  See the engadget, Wired, and Nature articles for more information.
  • The European Food Safety Authority (EFSA) and the European Center for Disease Prevention and Control (ECDPC) have issued a joint summary report on antimicrobial resistance in the EU based on data from its 28 Member States.
  • The 278-page report summarizes findings that antimicrobial resistance is increasing in bacteria that cause disease when transmitted from animals to humans (i.e., zoonotic diseases)—such as Campylobacter, Salmonella, and E. coli.  EFSA found that in some countries resistance of Campylobacter to ciprofloxacin and erythromycin, for example, is so high that there are few antibiotics left to treat severe infections in humans.  Further, methicillin-resistant Staphylococcus aureus (MRSA) was detected in pigs, calves, and hens, as well as meat from these food-producing animals.
  • As previously reported on this blog, antibiotic resistance continues to be of high concern for food safety authorities (including FDA), non-profit organizations, and corporations.
  • As previously reported on this blog, FDA’s comment period on the use of the terms, such as milk, yogurt, and cheese, in the labeling of plant-based products ended on January 28, 2019. FDA’s standard of identity for milk defines milk in part as the “lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.
  • On February 21, 2019, after the end of FDA’s comment period, the National Milk Producers Federation filed a citizen petition to FDA requesting that the agency: (1) enforce existing “imitation” labeling requirements against non-dairy substitutes for dairy foods; and (2) codify FDA policies to permit the name of a standardized dairy food to be used in the statement of identity of a non-dairy substitute for standardized food when products are deemed nutritionally equivalent to the dairy products they reference.
  • Pursuant to 21 CFR 10.30(e)(2), the FDA must respond to citizen petitions within 180 days of receipt although the response may not be substantive and could simply be that they need more time to review the citizen petition.  FDA action or response to its request for comments on labeling of plant-based products is also forthcoming.  We will continue to monitor this situation and report on any developments.